There is no worse tyranny than to force a man to pay for what he does not want merely because you think it would be good for him.

— Robert Heinlein

All laws which are repugnant to the Constitution are null and void.

— Marbury v. Madison, 5 US (2 Cranch) 137, 174, 176 (1803)

Right. But you cannot enforce this without the help of the courts. The right of the states to nullify unconstitutional federal laws (nothing in the Constitution prohibited it, and both Madison and Jefferson wrote in support of state nullification of the federal Alien and Sedition Acts) is impossible in the face of overwhelming federal military might. Ah, the dangers of standing armies that the Founders warned us of.

A General Accounting Office (GAO) study of FDA in 1975 revealed that 150 FDA officials owned stock in the companies they were supposed to regulate.

The FDA’s desperate battle to censor (in violation of the First Amendment) the communication by dietary supplement manufacturers and vendors of truthful and nonmisleading information on the effects of supplements on disease is part and parcel of the agency’s commitment to protecting the pharmaceutical industry from competition by dietary supplements. The big problem that we have now is that the courts cannot be relied upon to uphold and defend the Constitution and to strike down the agency’s self-interested distortions in the construction of statutes. Judges too often focus upon their fears of the consequences of the exercise of freedom of speech rather than that the federal government shall “make no law … abridging the freedom of speech” (First Amendment). How otherwise would we have gotten McCain-Feingold, a blatant federal abridgment of political free speech?

FLASH! Court Strikes Ephedra Ban

Wow! We have just received news (4/14/05) of an exciting and positive new development: the U.S. District Court, District of Utah, Central Division (Judge Tena Campbell presiding) has overturned the FDA’s Final Rule in which the agency banned all ephedra alkaloid-containing dietary supplements. This is a well-reasoned court decision (copy available from Cynthia Lewis or DuWayne Hamilton at Emord & Associates, 202-466-6937), in which the most important points go far beyond ephedra to an examination of the FDA’s interpretation of the powers granted to it by Congressional statute, which provide the only authority FDA has in dealing with dietary supplements. The court has found that the FDA has gone beyond its authority under the DSHEA (Dietary Supplement Health and Education Act) in its attempt to ban ephedra.

Although we were not parties to this suit, our brilliant constitutional law attorney, Jonathan Emord, represented the plaintiffs (Nutraceutical Corporation).

The FDA banned all ephedra-containing products on the basis of a risk-benefit analysis in which the agency declared that “in the absence of a sufficient benefit, the presence of even a relatively small risk of an important adverse health effect to a user may be unreasonable,” justifying (according to the agency) the agency’s conclusion that ephedra alkaloid-containing dietary supplements (EDS) “present a significant or unreasonable risk of injury,” thus meeting (supposedly) the adulteration provision in DSHEA, which permits the agency to ban a supplement’s sale.

However, nowhere in the DSHEA is there a provision authorizing FDA to conduct a risk-benefit analysis. The court notes that “The imposition of a risk-benefit analysis requires the producer of an EDS to establish a benefit and alleviates the burden Congress placed squarely on the government to demonstrate the existence of a significant or unreasonable risk.” In a footnote, the court agrees with the plaintiffs that if food producers had to “show a benefit as a precondition to sale, the sale of foods such as potato chips might be prohibited.” In fact, DSHEA provides that dietary supplements are to be regulated as foods, and foods are not required to provide evidence of a benefit for legal sale.

We realized at the time of the Final Rule that this usurpation of authority by the FDA to require the establishment of a benefit for a dietary supplement was not authorized by statute and constituted a serious risk to the future availability of any dietary supplement. It invoked drug requirements (establishing safety and efficacy) for dietary supplements. This court decision has clearly thrown out the FDA’s claim of authority to do risk-benefit analyses to regulate dietary supplements. In the FDA’s risk-benefit analysis for EDS, the FDA didn’t even allow for a weight-loss benefit because, although FDA admitted there was evidence to support a modest, short-term weight loss, the FDA couldn’t determine whether such weight loss was associated with improved health outcomes, such as improved cardiovascular risk factors. Of course, to determine the latter would have required at least one very large, extremely expensive intervention trial, as must be done for drugs. To require this of dietary supplements would mean that most dietary supplements could no longer be sold. The purpose of DSHEA, after all, was to prevent the FDA from regulating dietary supplements as drugs.

The court additionally found that “The plain language of the statute requires a dose-specific analysis. Legislative history also confirms Congress’ intent to require that a finding of adulteration be dose-specific: ‘a safety finding cannot be entered against a supplement based upon a dosage not recommended to consumers in the labeling.’” [Court quotes from Sen. Rep. No. 103-410 at 36] Hence, the FDA cannot simply ban all ephedra alkaloid-containing dietary supplements and has failed “to prove by a preponderance of the evidence that a dosage of 10 mg or less of ephedrine alkaloids presents a significant or unreasonable risk of illness or injury,” as required by the DSHEA in order to find a supplement to be “adulterated.”

Congratulations and many thanks to Jonathan Emord and his associates and Nutraceutical Corp. for this magnificent victory!

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